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Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. ("Dongbao Pharm" or the "Company") received an approval letter from the Drug Regulatory Authority of Pakistan (DRAP) for its human insulin drug substance (DS) product. This enables the Company to officially supply its human insulin DS to the Pakistani market, marking another achievement in its international strategy.
As a supplier of human insulin DS, the Company supported global customers in completing the registration filing and approval for marketing their drug products in Pakistan, through which the Company obtained this approval. This fully demonstrates the Company's competitiveness in global markets for its DS products. With more than two decades of experience in the insulin field, the Company has established a mature and stable system for large-scale DS manufacturing and a full-lifecycle quality control system, enabling it to reliably and continuously supply DS to global partners and jointly improve access to diabetes drugs.
Pakistan is one of the countries with the highest burden of diabetes in the world. According to the International Diabetes Federation (IDF) Diabetes Atlas 11th edition, approximately 34.53 million adults aged 20–79 in Pakistan were living with diabetes in 2024, with a prevalence rate as high as 26.5%, among the highest globally. The number of people with diabetes is projected to rise to 70.2 million by 2050. Based on the current IDF forecasts, Pakistan is expected to surpass the United States by that time to become the country with the third-largest number of people living with diabetes in the world.
At the same time, approximately 9.3 million (about 26.9%) adults with diabetes in Pakistan remain undiagnosed and face the risk of various complications. The large patient population and the significant gap in diagnosis and treatment are driving an urgent and growing need for high-quality, affordable insulin products in the Pakistani market.
The marketing approval of Dongbao Pharm's human insulin DS not only enables the Company to supply the product in Pakistan but also provides an important guarantee for local patients to gain access to safe and effective insulin treatment.
The breakthrough in the Pakistani market epitomizes the systematic advancement of Dongbao Pharm's international strategy. For its global product pipeline, the Company has established a comprehensive portfolio spanning human insulin, insulin analogs, and GLP-1 receptor agonists, and can offer high-quality, diversified treatment solutions tailored to patient needs in different markets.
Looking ahead, the IDF projects that the number of people living with diabetes worldwide will exceed 853 million by 2050. The huge market demand offers vast opportunities for high-quality insulin suppliers. Dongbao Pharm will keep deepening its international registration strategy, accelerate the market entry of its DS and drug products in more countries and regions, and contribute to the global diabetes treatment system, enabling more patients worldwide to access safe, accessible, and high-quality Dongbao Pharm products.